MAUDE Adverse Event Report: ARTHROCARE CORP. BEVEL 45 ICW; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	AC2430-01
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, during a shoulder arthroscopy with a wand, the patient's shoulder was scalded by water on the lateral side of the joint.The water had flowed out from equipment connection pipeline.Although a back-up device was available to complete the procedure, it is unknown if there was a surgery delay.The patient is currently undergoing follow-up treatment.No further were complications reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: the reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.The future impact to the patient beyond that which has already been reported is unknown.Should any other medical information be provided, this complaint will be re-assessed.No further medical assessment is warranted at this time.A review of the device history records for the device showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.Please refer to the instructions for use for recommendations on preventing patient burns.A review of risk management files found that the reported failure was documented appropriately.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.Reference: (b)(4).

• Brand Name: BEVEL 45 ICW
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 11140704
• Report Number: 3006524618-2021-00049
• Device Sequence Number: 16731823
• Product Code: GEI
• UDI-Device Identifier: 00817470004540
• UDI-Public: 00817470004540
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K033584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/23/2022
• Device Model Number: AC2430-01
• Device Catalogue Number: AC2430-01
• Device Lot Number: 2028187
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/21/2020
• Supplement Date Received by Manufacturer: 02/15/2021
• Initial Report FDA Received Date: 01/08/2021
• Supplement Report FDA Received Date: 02/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention